Toward Exercise as Medicine for Adolescents With Bipolar Disorder (TEAM-BD)

March 16, 2021 updated by: Dr. Benjamin Goldstein, Sunnybrook Health Sciences Centre

Toward Exercise as Medicine for Adolescents With Bipolar Disorder: A Feasibility Study

This study seeks to bridge the knowledge-to-action gap regarding "exercise as medicine" for adolescents with bipolar disorder (BD). Numerous review articles attest to widespread recognition that aerobic exercise (AE) could be an important part of the treatment armamentarium to reduce the symptom burden, neurocognitive dysfunction, and cardiovascular disease (CVD) risk, improve quality of life (QOL), and even engage core biological treatment targets in BD. It appears self-evident that treatment for adolescents with BD, who experience high symptom burden, neurocognitive deficits, and increased CVD risk, should target their aerobic fitness (AF), yet there is not a single study in the world literature on this topic. Remarkably, there have been no intervention studies that specifically focus on aerobic exercise or that directly evaluate changes in AF in any BD age group. Overall physical activity is important, but focusing on AF offers unique potential benefits in terms of simultaneously ameliorating and enhancing mood, neurocognition, and cardiovascular health. Importantly, a recent American Heart Association (AHA) Scientific Statement confirms that it is the most aerobically unfit for whom even modest improvements in AF offer the greatest relative benefits. Nonetheless, important questions arise as to whether and how AF in this population can be improved. There is a clear and unmet need for effective behavior change counseling (BCC) interventions targeting AF that are tailored to the unique needs of adolescents with BD.

Study Overview

Status

Terminated

Conditions

Detailed Description

The overarching goal of this project is to advance the field in terms of BCC approaches to improving AF among adolescents with BD, a group for whom improvements in AF offer multiple parallel benefits. This project will serve as a preliminary feasibility study, a necessary step in the path toward a well-powered, randomized controlled trial (RCT). If exercise is to achieve the same status as other evidence-based treatments for adolescents with BD, it will be necessary to evaluate exercise with the same level of rigor as other interventions. A crucial first step toward the ultimate goal of an adequately powered RCT is to demonstrate that adolescents with BD will enroll in, and actively participate in, an intervention study that accurately reflects what would be required of participants in such a study.

Objective 1: Evaluate the feasibility of developing a 24-week BCC intervention, customized and personalized for adolescents with BD, focusing on increasing AF.

Objective 2: Evaluate the feasibility of implementing the 24-week BCC intervention.

Objective 3: Evaluate the feasibility of measuring the effects of the intervention.

Exploratory: Examine the impact on AF of a 24-week BCC intervention, customized and personalized for adolescents with BD. Related hypothesis-generating analyses will examine the impact of specific variables (e.g., mood, medications, exercise-induced feelings, specific BCC modules, changes in motivation and self-efficacy) on AF changes.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • English-speaking
  • 13-21 years old
  • Meet diagnostic criteria for BD (using KSADS-PL)
  • Report moderate-vigorous exercise <150 minutes/week in the preceding 12 weeks
  • Written clearance from primary care physician required

Exclusion Criteria:

  • Unable to provide informed consent (e.g., severe psychosis, IQ<80)
  • Presence of hypo/hypertension and history of exercise induced and aggravated conditions that are contraindications to proceeding with the study (e.g., syncope, asthma)
  • Known cardiac condition (e.g., conduction abnormality, congenital heart disease) or other active medical condition that precludes aerobic exercise
  • Known respiratory condition that precludes aerobic exercise
  • Known health condition of physiological impairment that would preclude participation in exercise
  • Currently manic (PSR score of 5 or 6 on mania)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Adolescents with bipolar disorder
Forty adolescents (aged 13-21) with BD (type I, II, or not otherwise specified/other specified and related disorder) will be enrolled in the behavior change counseling intervention.

Core modules: 1 psychoeducation session at week 0; 4 behavior change counseling (BCC) sessions will occur at weeks 0, 4, 8, and 12; phone calls and/or texting sessions (weeks 1-3, 5-7, 9-11, and "booster" calls and/or texts on weeks 16 and 20) from therapists.

Optional modules: Exercise coaching sessions; family involvement options will include participation in any aspect of the intervention; peer support options will include: group exercise classes on site, online Fitbit groups where adolescents can participate in competitions with each other and provide motivational support, and fitness support groups facilitated by registered social workers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Barriers to participation using the Client Satisfaction Questionnaire
Time Frame: Week 12
Week 12
Barriers to participation using the Client Satisfaction Questionnaire
Time Frame: Week 24
Week 24
Satisfaction of patient, parent, and consumer advocate co-investigators using the Client Satisfaction Questionnaire
Time Frame: Week 12
Week 12
Satisfaction of patient, parent, and consumer advocate co-investigators using the Client Satisfaction Questionnaire
Time Frame: Week 24
Week 24
Percentage of target sample size enrolled
Time Frame: three years (At the end of study completion)
three years (At the end of study completion)
Percentage of screened participants meeting inclusion criteria comparing number of participants screened to number of participants who meet inclusion criteria
Time Frame: Three years
Evaluating whether sample reflects clinical population in which exercise is an anticipated intervention
Three years
Barriers to recruitment
Time Frame: Three years
Qualitative assessment using phenomenological approach
Three years
Therapist adherence with behavior change counseling using the Behavior Change Counseling Index
Time Frame: three years
three years
Participant attendance
Time Frame: Week 0
Attendance at core sessions
Week 0
Participant attendance
Time Frame: Week 4
Attendance at core sessions
Week 4
Participant attendance
Time Frame: Week 8
Attendance at core sessions
Week 8
Participant attendance
Time Frame: Week 12
Attendance at core sessions
Week 12
Participant attendance
Time Frame: Week 1
Attendance at phone calls/texting sessions
Week 1
Participant attendance
Time Frame: Week 2
Attendance at phone calls/texting sessions
Week 2
Participant attendance
Time Frame: Week 3
Attendance at phone calls/texting sessions
Week 3
Participant attendance
Time Frame: Week 5
Attendance at phone calls/texting sessions
Week 5
Participant attendance
Time Frame: Week 6
Attendance at phone calls/texting sessions
Week 6
Participant attendance
Time Frame: Week 7
Attendance at phone calls/texting sessions
Week 7
Participant attendance
Time Frame: Week 9
Attendance at phone calls/texting sessions
Week 9
Participant attendance
Time Frame: Week 10
Attendance at phone calls/texting sessions
Week 10
Participant attendance
Time Frame: Week 11
Attendance at phone calls/texting sessions
Week 11
Participant attendance
Time Frame: Week 16
Attendance at phone calls/texting sessions
Week 16
Participant attendance
Time Frame: Week 20
Attendance at phone calls/texting sessions
Week 20
Participant completion of daily activity logs
Time Frame: three years
Number of daily activity logs completed for each participant
three years
Participant attendance
Time Frame: Week 1
Attendance at exercise coaching session
Week 1
Percentage of participants who selected the exercise coaching optional module
Time Frame: three years
three years
Percentage of participants who selected the family focused counseling optional module
Time Frame: three years
three years
Percentage of participants who selected the peer support optional module
Time Frame: three years
three years
Percentage of participants who completed the 24 weeks of the study
Time Frame: three years
three years
Percentage of participants who completed the 12 week intervention
Time Frame: three years
three years
Percentage of participants who completed all aerobic fitness testing sessions
Time Frame: three years
three years
Percentage of sessions attended by each team member
Time Frame: three years
three years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in aerobic fitness using the Modified Bruce Protocol
Time Frame: From week 0 to week 12
The modified Bruce Treadmill Test (weeks 0, 12) progresses through stages every 3 minutes, with each stage increasing in incline of the treadmill platform and increasing speed of treadmill belt. The modified Bruce treadmill test will provide an estimation of VO2max based on treadmill time.
From week 0 to week 12
Change in aerobic fitness using the Modified Bruce Protocol
Time Frame: From week 12 to week 24
The modified Bruce Treadmill Test (weeks 12, 24) progresses through stages every 3 minutes, with each stage increasing in incline of the treadmill platform and increasing speed of treadmill belt. The modified Bruce treadmill test will provide an estimation of VO2max based on treadmill time.
From week 12 to week 24
Change in aerobic fitness using the Modified Canadian Aerobic Fitness Test
Time Frame: From week 2 to week 8
The modified Canadian AF Test (weeks 2, 8), consists of stepping up and down two steps (20.3 cm in height each) during 3-minute stages while listening to set cadences. The stepping rate will depend on age and sex, and participants will be required to reach a target heart rate of 85% of predicted maximum (220 - age). VO2 max will be estimated through the following equation: VO2 max = 32.5 +13.6 x estimated oxygen cost (L/min) - 0.24 x age - 0.17 x weight (Kg).
From week 2 to week 8
Schedule for Affective Disorders and Schizophrenia for School Age Children, Present and Life Version (K-SADS-PL)
Time Frame: baseline
The K-SADS-PL is a semi-structured interview designed to ascertain present episode and lifetime history of psychiatric illness, according to Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV criteria for children and adolescents.
baseline
Longitudinal Interval Follow-up Evaluation (LIFE)
Time Frame: baseline, week 12, week 24
The LIFE will provide a comprehensive cross-sectional and longitudinal picture of the symptomatic and psychosocial course and outcome of all participants in this study
baseline, week 12, week 24
Brief Quality of Life in Bipolar Disorder (QoL.BD)
Time Frame: baseline, week 12, week 24
The Brief QoL.BD is a self-report that will be used to assess condition-specific quality of life. Scale responses include: strongly disagree, disagree, neutral, agree, and strongly agree. The scale assesses 12 basic domains of quality of life: physical, sleep, mood, cognition, leisure, social, spirituality, finances, household, self-esteem, independence, and identity. Total scores can range from 12-60 with 60 identifying a high quality of life.
baseline, week 12, week 24
36-Item Short Form Health Survey (SF-36)
Time Frame: baseline, week 12, week 24
The SF-36 taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. To score, first, precoded numeric values are recoded per the scoring key given (see link). Note that all items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range. Scores represent the percentage of total possible score achieved. In step 2, items in the same scale are averaged together to create the 8 scale scores. Table 2 lists the items averaged together to create each scale. Items that are left blank (missing data) are not taken into account when calculating. https://www.rand.org/health/surveys_tools/mos/36-item-short-form/scoring.html
baseline, week 12, week 24
Client Satisfaction Questionnaire-8 (CSQ-8)
Time Frame: At weeks 12 and 24
The Client Satisfaction Questionnaire-8 will be used to assess intervention satisfaction. An overall score is calculated by summing the respondent's rating (item rating) score for each scale item. For the CSQ-8 version, scores therefore range from 8 to 32, with higher values indicating higher satisfaction. Scoring values range from 1-4 with 4 meaning high satisfaction and 1 meaning low satisfaction.
At weeks 12 and 24
The Stages of Change Questionnaire (SCQ)
Time Frame: baseline, week 4, week 8, week 12, and week 24
The Stages of Change Questionnaire is a self-report that will provide the stage of behavior change relating to exercise status for discussion at BCC sessions. Six statements are provided and the participant is asked to select the statement that best describes them. This will then determine which stage of change they are in (precontemplation, contemplation, preparation, action, maintenance, or relapse).
baseline, week 4, week 8, week 12, and week 24
Outcome Expectations for Exercise (OEE)
Time Frame: baseline, week 12, week 24
The Outcome Expectations for Exercise tool will assess expectations of the benefits from physical activity. The Outcome Expectations for Exercise Scale contains 9 statements rated by participants using a 5-point likert scale from 1 "Strongly Disagree" to 5 "Strongly Agree". If negative or low expectations are found, an intervention can be implemented that may increase the expectancy of exercise and therefore create a more active lifestyle.
baseline, week 12, week 24
Motives for Physical Activities Measure-Revised (MPAM-R)
Time Frame: baseline, week 12, week 24
The MPAM-R will assess motives for activity participation. There are five categories: interest/enjoyment, competence, appearance, fitness, and social. It is rated on a likert scale ranging from 1 (not at all true for me) to 7 (very true for me).
baseline, week 12, week 24
Behavioral Regulation in Exercise Questionnaire (BREQ-3)
Time Frame: baseline, week 12, week 24
The Behavioral Regulation in Exercise Questionnaire-3 is a 24-item self-report scale that assesses the reasons why people exercise. Questions range from 0 (not true for me) to 4 (very true for me). BREQ has been used either as a multidimensional instrument giving separate scores for each subscale, or as a unidimensional index of the degree of self-determination, known as the relative autonomy index. In order to use the BREQ as multidimensional scales, the mean scores are calculated for each set of items into categories (amotivation, external regulation, introjected regulation, identified regulation, integrated regulation, and intrinsic regulation).
baseline, week 12, week 24
Exercise Self-Efficacy
Time Frame: baseline, week 12, week 24
This measure will assess exercise-related self-efficacy. An 11-point scale is used with 1 indicating "not at all confident" and 7 indicating "very confident". Participants can also endorse 0 "does not apply to me". High scores indicate high levels of self-efficacy.
baseline, week 12, week 24
Quick Weight, Activity, Variety, and Excess Screener (WAVE)
Time Frame: baseline, week 12, week 24
WAVE is a 17-item self-report instrument that ascertains 5 subscales: weight, physical activity, dietary variety, dietary excess, and household food insecurity. The scores for each question can be added to generate an overall WAVE score that provides a quick estimate of the patient's overall health habits. The WAVE score can range from 0 to 21. The scores are interpreted as follows: 0 to 5= High priority for intervention to improve health habits; 6 to 11=In need of much improvement; 12 to 16=Some good health habits but needs improvement; and 17 to 21=Good to excellent health habits.
baseline, week 12, week 24
Drug Use Screening Inventory (DUSI)
Time Frame: baseline, week 12, week 24
Assesses drug use
baseline, week 12, week 24
Stressful Life Events Schedule (SLES)
Time Frame: baseline, week 12, week 24
The SLES (total score) ascertains 80 adolescent- and parent-reported negative life events, and their impact, during the preceding six months or time since last assessment. Participants responds whether or not an event has occurred and then rate how much the event affected them on a scale of 1 to 4 (1=not at all to 4=a lot).
baseline, week 12, week 24
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: baseline, week 12, week 24
The PSQI is a self-rated questionnaire which assesses sleep quality and disturbances over a 1 month time interval. Each question is scored with a total score of "5" or greater indicating poor sleep quality. Items collect time and length of sleep. Other items look at factors affecting sleep and responses range from 0 (not during the past month) to 3 (three or more times a week).
baseline, week 12, week 24
Exercise-Induced Feeling Inventory (EIFI)
Time Frame: baseline, then pre- and post-aerobic fitness testing at weeks 0, 2, 8, 12, and 24
The Exercise-Induced Feeling Inventory measures the intensity of 12 feeling states as they occur in relation to physical activity. Responses are rated from 0 (do not feel) to 4 (feel very strongly) for each emotion. The EIFI consists of 12 items that capture 4 distinct feeling states: revitalization, tranquility, positive engagement, and physical exhaustion. The EIFI consists of 4 distinct subscales. Subscale scores are obtained by summing or averaging the numerical values chosen for the adjectives within a particular subscale. The four subscales include: (1) Positive Engagement (items 4, 7, & 12), (2) Revitalization (items, 1, 6, & 9), (3) Tranquility (items 2, 5, & 10), and (4) Physical Exhaustion (items, 3, 8, & 11).
baseline, then pre- and post-aerobic fitness testing at weeks 0, 2, 8, 12, and 24
Physical Activity Logs
Time Frame: Through study completion, an average of 24 weeks
The physical activity logs will be used by participants to record any moderate to vigorous intensity exercise, including details such as the time of day, type of exercise, and thoughts, feelings and physical sensations in regards to the exercise
Through study completion, an average of 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Benjamin I Goldstein, MD, PhD, Senior Scientist, Psychiatrist

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2018

Primary Completion (Actual)

August 21, 2020

Study Completion (Actual)

August 21, 2020

Study Registration Dates

First Submitted

April 23, 2018

First Submitted That Met QC Criteria

June 18, 2018

First Posted (Actual)

June 19, 2018

Study Record Updates

Last Update Posted (Actual)

March 18, 2021

Last Update Submitted That Met QC Criteria

March 16, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 007-2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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